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NCT00544830 · ClinicalTrials.gov registry record · Phase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
A Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and PSA Level Greater Than Two, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT00544830: Active Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and PSA Level Greater Than Two, sponsored by City of Hope Medical Center.
NCT00544830 is a Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and PSA Level Greater Than Two that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 29 participants, below the 162-participant average among 7 other Stage IV Prostate Adenocarcinoma AJCC v7 trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00544830, a Phase 2 study of Stage IV Prostate Adenocarcinoma AJCC v7 and PSA Level Greater Than Two, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using goserelin, leuprolide acetate, or bicalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving hormone therapy and intensity-modulated radiation therapy may work better in treating patients with prostate cancer.
Primary Outcome
Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to \> 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is \> 10, while a patient with pre-treatm
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
- DRUG Bicalutamide
- DRUG Goserelin Acetate
- DRUG Leuprolide Acetate
Study Locations (2)
California
- City of Hope Medical Center - Duarte
- City of Hope South Pasadena - South Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-07-18 |
| Est. Completion | 2026-03-09 |
| Phase | Phase 2 |
What the registry record for NCT00544830 still lists
NCT00544830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 162-participant average among 7 other Stage IV Prostate Adenocarcinoma AJCC v7 trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Stage IV Prostate Adenocarcinoma AJCC v7 appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00544830 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00544830 about?
NCT00544830 is a clinical study titled "Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer". This phase II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using goserelin, leuprolide acetate...
What is the current status of trial NCT00544830?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2006-07-18. Estimated completion is 2026-03-09.
What conditions does trial NCT00544830 study?
This clinical trial studies the following conditions: Stage IV Prostate Adenocarcinoma AJCC v7, PSA Level Greater Than Two.
What interventions are being tested in trial NCT00544830?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), Bicalutamide (DRUG), Goserelin Acetate (DRUG), Leuprolide Acetate (DRUG).
Who is sponsoring clinical trial NCT00544830?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00544830 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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